DiabetesNCT01348685
Comparing Liquid Versus Solid Forms of Sugars and Whey Protein
A study testing Compare the effect of solid vs. liquid forms of sugars on satiety and food intake, the effect of solid vs. liquid forms of gelatin on appetite and food intake and The effect of solid vs. liquid forms of whey protein on food intake in people with Diabetes and Obesity, run by University of Toronto at 1 site in Canada.
Trial summary
To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its component mixtures and whey protein on subjective appetite and food intake in young men. Read more about this study
- Who is it for?
- Ages 19 to 28 years, men onlyHealthy volunteers can take part
- What is being tested?
- Compare the effect of solid vs. liquid forms of sugars on satiety and food intake, the effect of solid vs. liquid forms of gelatin on appetite and food intake and The effect of solid vs. liquid forms of whey protein on food intake
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy lean males with BMI between 18- 24.9 kg/m2 and an age range of 19 to 28 years were recruited for the three experiments.
Who cannot join
- Diabetics (fasting blood glucose ≥ 7.0 mmol/L), smokers, breakfast skippers or dieters were excluded from the experiments. Individuals under medications or with a history of liver or kidney disease and major medical or surgical event within the last six months were excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2
About this study
Official title: Effect of Drinking Liquid Compared to Eating Solid Treatment of Sugars or Whey Protein on Short-term Appetite and Food Intake
To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its component mixtures and whey protein on subjective appetite and food intake in young men.
Read the detailed description
Three randomized cross-over design experiments were used to compare the effect of solid and liquid forms of gelatin (6 g) in experiment 1, sucrose (75 g) and a mixture of 50% glucose/ 50% fructose (G50:F50) in experiment 2, and acid and sweet whey protein (50 g) in experiment 3 on healthy normal weight males . The controls were water (experiment 1 and 3) and calorie-free sweetened water with gelatin (sweet gelatin, experiment 1) or without gelatin (sweet control, experiment 2). Subjective average appetite was measured by visual analogue scales frequently over 1 h and ad libitum food intake was measured 1 h after the treatment consumptions.
- Being tested
- Compare the effect of solid vs. liquid forms of sugars on satiety and food intake, the effect of solid vs. liquid forms of gelatin on appetite and food intake, The effect of solid vs. liquid forms of whey protein on food intake
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare the effect of solid vs. liquid forms of sugars on satiety and food intakeOther
the effect of solid vs. liquid forms of gelatin on appetite and food intakeOther
The effect of solid vs. liquid forms of whey protein on food intakeOther
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective appetite and short term food intake
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Mondelēz International, Inc., Canadian Sugar Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348685
- Sponsor's protocol ID
- Solid and liquid 1
- Status last verified
- Feb 2011
- First submitted
- 4 May 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Drinking Liquid Compared to Eating Solid Treatment of Sugars or Whey Protein on Short-term Appetite and Food Intake
- ClinicalTrials.gov ID
- NCT01348685
- Acronym / sponsor ID
- Solid and liquid 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Mondelēz International, Inc., Canadian Sugar Institute
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its component mixtures and whey protein on subjective appetite and food intake in young men.
Detailed description
Three randomized cross-over design experiments were used to compare the effect of solid and liquid forms of gelatin (6 g) in experiment 1, sucrose (75 g) and a mixture of 50% glucose/ 50% fructose (G50:F50) in experiment 2, and acid and sweet whey protein (50 g) in experiment 3 on healthy normal weight males . The controls were water (experiment 1 and 3) and calorie-free sweetened water with gelatin (sweet gelatin, experiment 1) or without gelatin (sweet control, experiment 2). Subjective average appetite was measured by visual analogue scales frequently over 1 h and ad libitum food intake was measured 1 h after the treatment consumptions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 19 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy lean males with BMI between 18- 24.9 kg/m2 and an age range of 19 to 28 years were recruited for the three experiments.
Key exclusion criteria (1 listed)
- Diabetics (fasting blood glucose ≥ 7.0 mmol/L), smokers, breakfast skippers or dieters were excluded from the experiments. Individuals under medications or with a history of liver or kidney disease and major medical or surgical event within the last six months were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compare the effect of solid vs. liquid forms of sugars on satiety and food intake | Other | – |
| the effect of solid vs. liquid forms of gelatin on appetite and food intake | Other | – |
| The effect of solid vs. liquid forms of whey protein on food intake | Other | – |
Primary outcome
subjective appetite and short term food intake
Time frame: 60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
Related trials for Diabetes
Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compare the effect of solid vs. liquid forms of sugars on satiety and food intake, the effect of solid vs. liquid forms of gelatin on appetite and food intake and The effect of solid vs. liquid forms of whey protein on food intake in people with Diabetes and Obesity, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective appetite and short term food intake (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.